Biology W3995

Introduction to Clinical Research in Emergency Medicine

Columbia University, Fall 2008

                       

 

David H. Newman, MD

Director of Clinical Research

St. Luke’s/Roosevelt Hospital Center

Department of Emergency Medicine

1111 Amsterdam Ave

New York, NY 10025

212-523-3981

E-mail dnewman@chpnet.org

 

Office Hours will be arranged on an individual basis, please email or call.

 

Course Description:  This course is designed to introduce students who are interested in medical careers to the goals, nomenclature, principles, and practical reality of clinical research, with an emphasis on the emergency department (ED) setting. The course focuses on terminology, data collection techniques, research design, and basic biostatistics.  Understanding research and clinical emergency medicine as an avenue to understanding clinical studies and their implications will be emphasized. Group exercises will include design and implementation of two factitious hypothetical studies where funding, time scale, and resource availability will be considered. A mid-term examination will concentrate on terminology, data collection techniques, and a final examination will focus on research design. Basic didactic biostatistics material will be taught primarily for purposes of familiarization and interpretation of research and will be aimed at the non-mathematician (no Math or Statistics pre-requisites). There will be an option for a 1-point or 2-point version of the course when registering. The 1-point course will include didactic material and one lecture per week, and will not include ED time. The 2-point course (limited to 40 students per semester) in which students will act as research assistants will require inclusion in the Academic Associates research assistant program at St. Luke's/Roosevelt Hospital ED. This includes two 4-hour shifts per week of ED time in which students will learn how to assist in the execution of clinical research including performing consents, data collection, and database interaction (for further details regarding the Academic Associate program, see the web site (http://www.columbia.edu/cu/aap/). ED time will be arranged to fit in and around the student's academic schedule as needed. Additionally, three to five evening practical sessions will cover ongoing individual ED projects in depth, and students will be shown and instructed on basic procedural skills in emergency medicine (lumbar puncture, endotracheal intubation, etc.) as well as shown dynamic and static invasive imaging including ultrasound, CT scans, and others.

The 2-point course is recommended for those students looking to gain clinical research experience and hands on ED time with physicians in the clinical setting.

 

Lecture Time: T 5:40-7:20

 

Room: TBA

 

Website:  Courseworks will be utilized for posting of electronic materials.

 

Text: TBA. Most relevant reading materials will be handed out. | A user-friendly medical dictionary will be helpful

 

Reserve Readings:  Copies of reading assignments will be handed out and put on reserve.

 

Lectures:  See lecture schedule below. Sporadic evening sessions during the semester, in addition to lectures, will address specific research projects and their related anatomy, physiology, and research methodology, as well as practical and clinical skills. Sessions will be given by Dr. Newman and other emergency medicine and research faculty. 

 

Clinical: Two shifts total per week as a research assistant in the St. Luke’s or Roosevelt Hospital Emergency Department are required. Shift attendance is mandatory. Orientation for shifts will occur early, occasionally during the first week of class; pre-registration is highly recommended.

 

Exams: Mid-term covering the first half of the course and a final exam emphasizing the final half.

 

Grading:

Mid-term -         35%

Final -               35%

Participation -    30%

Shift attend. -     Variable (missed shift policy to be discussed in class)

 

 

Date

Lecture

Discussion

Reading

Lecture 1

Intro/Overview

Purpose/goals of clinical research

Do designated drivers
stay sober
(pdf)

Lecture 2

Basic study nomenclature

Terminology and precision

Handout

Lecture 3

Data collection techniques

Research assistant role in the clinical setting

Handout

Lecture 4

Biostats 1

Review/discussion

Handout

Lecture 5

Institutional Review Board/ Biostats 2

Federal regulation and subject protection

Handout

Lecture 6

Mid-term

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Lecture 7

Research Design

Case reports, surveys, cohort studies

Handout

Lecture 8

Research Design

Case-control studies, Randomized controlled trials

Handout

Lecture 9

Research Design

Group exercise - design of 2 factitious studies

Handout

Lecture 10

Reading studies

Understanding research (lay vs scientific press)

Handout

Lecture 11

Peer Review

Intro to scientific journals, peer review

Handout

Lecture 12

Final Examination

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